Skip to main content
OpenTrials
Completed

NCT Number: NCT02458313

Nicotinic Agonist Effects on BMI and Neuronal Response

Obesity is a serious and growing health problem in the United States. Obesity is associated with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased quality of life and increased mortality. Given the health and quality-of-life effects of obesity, developing effective treatments clearly is an important goal.

This study plans to learn more about the effects of an investigational new drug (DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to affect appetite, the investigators are interested in studying effects of the study drug, which has some similarities to nicotine, on how your brain responds to such things as pictures of food. The study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado

Denver, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight/obese (BMI > 27)
  • Between 21-65 years old

Exclusion criteria

  • Known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension
  • Women capable of conception (must be post-menopausal, surgically sterilized, or have adhered to an anti-contraception birth control regimen for at least 1 year)
  • Nicotine use
  • Significant endocrine/metabolic disease
  • Kidney disease
  • Neurological illness
  • Liver disease
  • Medication use affecting appetite and/or metabolism
  • MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

Treatment and study plan

DMXB-A

Drug

150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.

Other names: 3-(2,4-dimethoxybenzylidene anabaseine

Placebo

Other

Placebo capsules b.i.d. for 12 weeks

Primary outcomes

  1. Neuronal Response to Visual Food Cues

    Time frame: 14 weeks

    Neuronal response (insula) while viewing visual food cues

  2. Resting-state Neuronal Response

    Time frame: 14 weeks

    Neuronal response (default mode network) during rest

Secondary outcomes

  1. Body Weight

    Time frame: 14 weeks

    Body weight

  2. Fat Mass

    Time frame: 14 weeks

    Fat mass

  3. Appetite Rating

    Time frame: 14 weeks

    Hunger ratings via VAS scale (0-100)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2015
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.